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(Ampoule Leak Testing) Water-Bath Sterilizer

(Ampoule Leak Testing) This water‑bath sterilizer employs internationally advanced high‑temperature superheated water shower technology, using high‑temperature deionized water as the sterilization medium. A circulation pump creates a continuous spray‑circulation within the sterilization chamber, ensuring uniform heating of liquid containers such as ampoules, vials, and tubular bottles. It offers a wide temperature control range and excellent temperature uniformity, effectively preventing secondary contamination during operation. The equipment is equipped with a computer‑controlled system that enables automatic F0 value calculation and real‑time monitoring of the sterilization process. After sterilization, cooling water indirectly cools the spray water, providing forced cooling to the liquid containers and preventing prolonged exposure to high temperatures that could degrade the pharmaceutical solution, while also mitigating the risk of container rupture caused by direct contact between the cooling water and the containers. In addition, the system can be integrated with a vacuum‑and‑colored‑water leak‑testing method, reliably detecting defective products and ensuring the integrity of drug packaging. It is suitable for high‑temperature sterilization, leak testing, and cleaning of injectable and oral liquid products in the pharmaceutical, medical, and research sectors, and complies with GMP and relevant pressure vessel standards.

Equipment Features:

1. Movable door structure, with a detachable gear block design; the motor drives vertical lifting and lowering.
2. Double-door pass-through type, equipped with a pressure safety interlock; the liquid-handling program includes a temperature‑based door safety interlock.
3. The inflation‑pressure‑driven sealing ring provides automatic sealing. Featuring a brand‑new, high‑quality, highly tear‑resistant silicone rubber material, this circular hollow door seal boasts a specially coated surface that is both wear‑resistant and smooth, delivering superior sealing performance and an extended service life of up to 1,500 cycles.
4. The main structure features a rectangular cross-section and an欧式 ring‑type reinforcing rib configuration. The sealing groove is directly welded to the annular sleeves at both ends (GETINGE design).
5. Control System: Equipped with an imported Siemens programmable logic controller (PLC) and a color touchscreen, the system features fully automated process control and automatically displays operating status, temperature, pressure, time, and other parameters.
6. Traceability System: Equipped with a communication interface for connecting to the traceability system and providing a software communication protocol for such connectivity.
7. Equipped with sterilization programs for liquids, soft bags, vials, ampoules, injectables, oral solutions, as well as custom programs, along with test procedures such as BD testing.
8. Real-time printing of process data via a built-in micro‑needle printer, equipped with a data logger; independent generation of sterilization reports in both tabular and graphical formats, with cross‑checking against the control system.
9. The back-pressure rapid cooling system enables fast cooling of sterilized items.
10. Piping System: Sanitary-grade 304 stainless steel piping with clamp‑type connections; all welds are executed using an automated pipe welding machine. The primary control valves are imported German GEMÜ angle‑seat valves and Taiwanese Airtac solenoid valves, while the vacuum pump is an imported German SPECK direct‑drive liquid‑ring type. A high‑flow pipeline pump from France’s DFS is also employed. The circulation loop incorporates parallel branch lines that bypass the heat exchanger, ensuring rapid pure‑water circulation, minimizing excessive temperature differentials between upper and lower sections, and maintaining uniform temperature distribution.

Technical Specifications

Serial number	Technical Specifications	Design Specifications
1	Main material	The inner liner, door panel, and piping are all made of S30408 stainless steel, with a designed service life of up to 10 years.
2	Design pressure of the inner chamber	-0.1~0.3 MPa
3	Design temperature	150℃
4	Maximum operating temperature	138℃
5	Operating temperature	80~126℃
6	Maximum working pressure	0.25MPa
7	Relief valve opening pressure	0.28MPa
8	Temperature display accuracy	0.1℃
9	Pressure display accuracy	0.1KPa
10	Temperature uniformity	±1℃

Specification and Model

Product model	Inner liner dimensions (mm)		Volume (L)	External dimensions mm	Power supply	Power
Product model	Width × Height	Depth	Volume (L)	Length × Width × Height	Power supply	Power
WG-S0.25JS	550×550	845	250	1150×1340×1880	380V, 50HZ	2.5KW
WG-S0.36JS	610×610	1000	360	1320×1350×1930	380V, 50HZ	3KW
WG-S0.6JS	610×910	1150	600	1470×1450×2100	380V, 50HZ	3KW
WG-S0.8JS	610×910	1490	800	1820×1450×2100	380V, 50HZ	3.5KW
WG-S1.0JS	610×910	1815	1000	2150×1450×2100	380V, 50HZ	3.5KW
WG-S1.2JS	680×1180	1500	1200	1820×1520×2050	380V, 50HZ	4KW
WG-S1.5JS	680×1180	1900	1500	2220×1520×2050	380V, 50HZ	4KW
WG-S2.0JS	900×1380	1650	2000	1980×1860×2160	380V, 50HZ	5KW
WG-S2.5JS	900×1392	2000	2500	2350×1860×2160	380V, 50HZ	6KW
WG-S3.0JS	900×1380	2494	3000	2830×1950×2160	380V, 50HZ	6KW
WG-S4.0JS	900×1380	3250	4000	3580×1950×2160	380V, 50HZ	7.5KW
WG-S5.0JS	900×1392	4100	5000	4460×1950×2160	380V, 50HZ	11.5KW
WG-S6.0JS	900×1380	4800	6000	5150×2000×2160	380V, 50HZ	15KW

(Ampoule Leak Testing) Water-Bath Sterilizer

(Ampoule Leak Testing) The water‑bath sterilizer employs internationally advanced high‑temperature superheated water shower technology, using high‑temperature deionized water as the sterilization medium. A circulation pump drives a continuous spray‑circulation within the sterilization chamber, ensuring uniform heating of liquid vials such as ampoules, vials, and tubular bottles. It offers a wide temperature control range and excellent temperature uniformity, effectively preventing secondary contamination during operation.

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sales@jibimed.com

postmaster@chengyi-cn.com

Classification :

Water Bath Sterilizer

Keywords : (Ampoule Leak Testing) Water-Bath Sterilizer

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Production Control

With a 30,000 square meter cleanroom, we conduct weekly testing of air settle plate counts, surface microbial colonies, and disinfection of personnel's hands to maintain a clean production environment. Through these measures, we ensure safety and high quality standards.